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Two Different Tranexamic Acid Regimens in Coronary Artery Bypass Surgery

The Effect of Two Different Tranexamic Acid Dose Regimens on Intraoperative and Postoperative Bleeding in Coronary Artery Bypass Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05994989
Enrollment
90
Registered
2023-08-16
Start date
2023-08-14
Completion date
2024-10-21
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Hemorrhage

Keywords

Tranexamic acid, Coronary artery bypass, Hemorrhage

Brief summary

The primary aim of this study is to observe the effects of two different methods of administering tranexamic acid (i.v. bolus and i.v. infusion) routinely used intraoperatively in cardiovascular surgery, on patients' postoperative bleeding amounts. According to the hypothesis established in this study, it is anticipated that administering tranexamic acid as an i.v. bolus dose followed by an 8-hour continuous infusion will result in a more stable blood level compared to the sole i.v. bolus application, thereby being more effective in influencing postoperative bleeding levels. The study has been designed as a prospective observational research. The outcomes of two different tranexamic acid protocols applied during cardiovascular surgical procedures will be compared. The first group will consist of patients who receive a 10 mg/kg i.v. bolus of tranexamic acid after anesthesia induction, followed by an 8-hour i.v. tranexamic acid infusion at a dose of 2 mg/kg/hour. Group 2 will consist of patients who receive three doses of tranexamic acid, 10 mg/kg i.v. bolus after anesthesia induction, in the pump, and after protamine sulfate administration. The cases collected over a period of 14 months will be divided into two groups and compared in terms of intraoperative and postoperative bleeding levels, as well as their need for blood products.

Interventions

None listed

Sponsors

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who have coronary artery disease requiring coronary artery bypass surgery with cardiopulmonary bypass and received intravenous tranexamic acid either as a bolus or infusion during the intraoperative period will be included in the study. * Writen consent obtained

Exclusion criteria

* Patients operated on for reasons other than coronary artery bypass surgery * Patients who operated on as emergencies * Patients who have preoperative liver/renal dysfunction or a history of cerebrovascular events * Patients under the age of 18 * Patients who have coagulation disorder * Patients who have a history of allergies * Pregnancy or lactation * Disabled in spirit or law

Design outcomes

Primary

MeasureTime frameDescription
Postoperative hemorrhagePostoperative 1st, 6th and 24th hoursThe amount of bleeding within the first 24 hours postoperatively will be compared.

Secondary

MeasureTime frameDescription
Postoperative hemorrhagePostoperative first 24 hoursThe amounts of blood and blood products administered within the first 24 hours of postoperative

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026